metoprolol tartrate tablet film coated

INDICATIONS AND USAGE Hypertension Metoprolol tartrate tablets are indicated for the treatment of Hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of Angina Pectoris. Myocardial Infarction Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute Myocardial Infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS and WARNINGS ).

mylan institutional inc.

FDA Reported Adverse Reactions
`[1] off label use` `[2] fatigue` `[3] drug ineffective` `[4] pain` `[5] nausea` `[6] headache` `[7] pyrexia` `[8] arthralgia` `[9] dyspnoea` `[10] toxicity to various agents`

6 years ago

ROUND BLUE M 47

HOW SUPPLIED:

METOPROLOL TARTRATE Tablets, USP are available containing 25 mg or 50 mg of

METOPROLOL TARTRATE, USP. The 25 mg tablets are white, film-coated, round, scored tablets debossed with M over 18 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-255-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 50 mg tablets are pink, film-coated, round, scored tablets debossed with M over 32 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-801-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12628 6/20

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